Trial · NCT00048893
Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer
NCT00048893, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2012-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer. Trials, record NCT00048893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00048893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer
- NCT number
- NCT00048893
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Breast Neoplasms, Metastases, Neoplasm
- Interventions
- recombinant fowlpox-CEA(6D)/TRICOM vaccine, recombinant vaccinia-CEA(6D)/TRICOM vaccine, filgrastim, sargramostim, cyclophosphamide, doxorubicin hydrochloride, fludarabine phosphate, paclitaxel, Mesna
- First posted
- 2002-11-11
- Last updated
- 2012-04-13
- Results first posted
- 2012-04-13
- Limitations and caveats
- The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-free Survival as Measured by Clinical Evaluation and Tumor Measurements by Imaging | time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study | Complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is a decrease of greater than or equal to 50% in the sum of the products of the longest perpendicular dimensions of all measurable target lesions. Stable disease (SD) is any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions of measurable disease. Progressive disease (PD) is a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease. |
| Primary | Number of Participants With Adverse Events | 91 months | Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
| Secondary | Log Change in Precursor Frequency as Measured by Elispot. | time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study | The log change in CEA-specific T cell precursor frequency will be calculated between values obtained at baseline and 5 months post immune depletion. A change equal to 1.0 standard deviation (SD) of the log change is significant. |
| Secondary | Log Change of CD4 CEA-specific Immune Responses and Their Kinetics as a Surrogate Marker for Clinical Anti-tumor Activity of the Vaccines | Baseline and 5 months post immune depletion | Response is evaluated by CD4 response to CEA soluble protein. The log change in precursor frequencies will be calculated between values obtained at baseline and five months post immune depletion. By flow cytometry of peripheral blood lymphocyte frequency of potential killer cells directed to the CEA protein. |
| Secondary | Immune Response to the Vaccine in Those Patients With Late Recovery of Thymic Function | 2 years | It is expected that delayed administration of a vaccine will result in enhancement of immune response to the vaccine in those patients with later recovery of thymic function as evidenced by change in lymphocyte subsets in the blood. |
| Secondary | Number of Months of Progression Free Survival | After the immune depletion cycle | The time period a participant remains free from progressive disease. Progressive disease (PD) is defined as a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease or the appearance of new disease or an increase in evaluable disease. |
| Secondary | Number of Participants With an Immune Response as a Result of the Salvage Immunization Schedule | 6 weeks, than 6, 12, 18, 24, 30, 36 (3y), 42, 48 (4y), 60 and 72 months after completion of immune chemotherapy | Patients showing disease progression or recurrence at any point after the start of the early immunizations series may continue on study in accordance to the off study criteria and will be receiving monthly rF immunizations for a total of 12 months or until further disease progression meets the off study criteria. Immune response as evidenced by change in lymphocyte subsets in the blood. |
| Secondary | Number of Participants With a Clinical Response | At the beginning of each cycle of chemotherapy (every 4 weeks) | Defined as measurable disease (any solid lesion that can be measured accurately in at least one dimension), evaluable disease (disease not readily measurable but can be clinically assessed), complete response (complete disappearance of all measurable and evaluable disease), partial response (decrease of greater than or equal to 50%), stable disease (any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions), or progressive disease (greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event-free Survival as Measured by Clinical Evaluation and Tumor Measurements by Imaging | time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study | The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done. | Months | NUMBER |
| PRIMARY | Number of Participants With Adverse Events | 91 months | Participants | NUMBER | |
| SECONDARY | Log Change in Precursor Frequency as Measured by Elispot. | time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study | The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done. | log change in CEA-specific T cell precur | NUMBER |
| SECONDARY | Log Change of CD4 CEA-specific Immune Responses and Their Kinetics as a Surrogate Marker for Clinical Anti-tumor Activity of the Vaccines | Baseline and 5 months post immune depletion | The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done. | log change of CD4 CEA specific precursor | NUMBER |
| SECONDARY | Immune Response to the Vaccine in Those Patients With Late Recovery of Thymic Function | 2 years | The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done. | Cells/L | NUMBER |
| SECONDARY | Number of Months of Progression Free Survival | After the immune depletion cycle | The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done. | Months | NUMBER |
| SECONDARY | Number of Participants With an Immune Response as a Result of the Salvage Immunization Schedule | 6 weeks, than 6, 12, 18, 24, 30, 36 (3y), 42, 48 (4y), 60 and 72 months after completion of immune chemotherapy | The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done. | Participants | NUMBER |
| SECONDARY | Number of Participants With a Clinical Response | At the beginning of each cycle of chemotherapy (every 4 weeks) | The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 11 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 37 | |
| Overall Study | COMPLETED | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 37 | |
| Overall Study | NOT COMPLETED | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 0 |
Source ClinicalTrials.gov
Adverse events131
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 4 | 37 | 4 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 4 | 37 | 4 |
| other | Allergy-Other (Specify, itching & red splotches due to shellfish) | Immune system disorders | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 1 | 37 | 1 |
| other | Autoimmune reaction | Immune system disorders | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 1 | 37 | 1 |
| other | Hemoglobin | Blood and lymphatic system disorders | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 10 | 37 | 172 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 10 | 37 | 169 |
| other | Lymphopenia | Blood and lymphatic system disorders | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 10 | 37 | 70 |
| other | Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 10 | 37 | 118 |
| other | Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol | Blood and lymphatic system disorders | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 1 | 37 | 1 |
| other | Platelets | Blood and lymphatic system disorders | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 10 | 37 | 11 |
1 to 10 of 131Source ClinicalTrials.gov
See all 131 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | ||
| Total, other adverse events | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 11 | 37 |
| Total, serious adverse events | Carcinoembryonic Antigen (CEA)-Tricom Vaccines | 11 | 37 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00048893
GET https://conductscience.org/api/trials/v1/NCT00048893/events?page=2